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A Certification-Based Modeling Approach of Medical Cyber-Physical Systems: An Insulin Infusion Pump Case Study

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17th International Conference on Information Technology–New Generations (ITNG 2020)

Abstract

Medical Cyber-Physical Systems (MCPS) are safety-critical systems composed of hardware and software components that interact one each other and with the environment. Interactions of system and environment generate emergent properties that manufacturers should analyze to avoid hazard situations. The main contribution presented in this paper is a certification-based modeling approach of MCPS described by means of an insulin infusion pump case study. The modeling approach combines assurance cases in modular Goal Structuring Notation (GSN) and formal modeling tools to carry out a model-driven and goal-oriented requirements engineering. Assurance case models in modular GSN are specified along with requirements of an infusion pump system based on formal methods, and an Arduino prototype was designed during the case study. Manufacturers may reuse the approach as a source of safety and effectiveness evidence during a certification process.

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References

  1. Hawkins, R., Habli, I., Kelly, T., McDermid, J.: Assurance cases and prescriptive software safety certification: a comparative study. Saf. Sci. 59, 55–71 (2013)

    Article  Google Scholar 

  2. Brown, A.W., Conallen, J., Conallen, D.: Introduction: models, modeling, and model-driven architecture (mda). In: Model-Driven Software Development. Springer, Heidelberg (2005)

    Google Scholar 

  3. Agha, G.: Actors: A Model of Concurrent Computation in Distributed Systems. MIT Press, Cambridge (1986)

    Google Scholar 

  4. GSN community standard version 1 [Online]. Available: https://scsc.uk/r141:1?t=1 (2011). Accessed 09 Sep 2019

  5. FDA: Insulin Pump Improvement Initiative White Paper [Online]. Available: https://www.fda.gov/medical-devices/infusion-pumps/white-paper-infusion-pump-improvement-initiative (2010). Accessed 05 Sep 2019

  6. Méry, D., Singh, N.K.: Formal specification of medical systems by proof-based refinement. ACM Trans. Embed. Comput. Syst. 12, 1–25 (2013)

    Article  Google Scholar 

  7. Dechev, D., Stroustrup, B.: Model-based product-oriented certification. In: Engineering of Computer Based Systems. IEEE Computer Society, Los Alamitos (2009)

    Google Scholar 

  8. Silva, L.C., Almeida, H.A., Perkusich, A., Perkusich, M.: A model-based approach to support validation of medical cyber-physical systems. Sensors. 15, 27625–27670 (2015)

    Article  Google Scholar 

  9. Sobrinho, A., Silva, L.D., Perkusich, A., Cunha, P., Cordeiro, T., Lima, A.M.N.: Formal modeling of biomedical signal acquisition systems: source of evidence for certification. Software and Systems Modeling. 18(2), 1–19 (2017)

    Google Scholar 

  10. Horkoff, J., Aydemir, F.B., Cardoso, E., Li, T., Mattia, A., Paja, E., Salnitri, M., Mylopoulos, J., Giorgini, P.: Goal-oriented requirements engineering: a systematic literature map. In: International Requirements Engineering Conference. IEEE, Piscataway (2016)

    Google Scholar 

  11. Diabetes.co.uk: Basal Bolus-Basal Bolus Injection Regimen [Online]. Available: https://www.diabetes.co.uk/insulin/basal-bolus.html (2019). Accessed 05 Sep 2019

  12. ASTM International: ASTM F2761-09 – Medical Devices and Medical Systems Essential Safety Requirements for Equipment Comprising the Patient-Centric Integrated Clinical Environment (ICE), Part 1: General Requirements and Conceptual Model. ASTM International, West Conshohocken (2013)

    Google Scholar 

  13. Berkeley, U.C.: The Ptolemy Project: Heterogeneous, Modeling and Design. EECS Dept. Available online: http://ptolemy.eecs.berkeley.edu/ptolemyII

  14. Mathworks: Simulink Design Verifier (2012)

    Google Scholar 

  15. Jensen, K., Kristensen, L.M.: Colored petri nets: a graphical language for formal modeling and validation of concurrent systems. Commun. ACM. 58, 51–70 (2015)

    Article  Google Scholar 

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Correspondence to Lenardo Chaves e Silva .

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e Silva, L.C. et al. (2020). A Certification-Based Modeling Approach of Medical Cyber-Physical Systems: An Insulin Infusion Pump Case Study. In: Latifi, S. (eds) 17th International Conference on Information Technology–New Generations (ITNG 2020). Advances in Intelligent Systems and Computing, vol 1134. Springer, Cham. https://doi.org/10.1007/978-3-030-43020-7_66

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  • DOI: https://doi.org/10.1007/978-3-030-43020-7_66

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-43019-1

  • Online ISBN: 978-3-030-43020-7

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